Valve Permitting Mixing in a Drug Delivery Device

ABSTRACT

A valve ( 10 ) for permitting mixing of at least two components within a barrel ( 12 ) is provided including a stopper ( 20 ) configured for slidable liquid-tight engagement with an inner surface ( 13 ) of the barrel. The stopper is moveable between a first position and a second position and includes a proximal end ( 22 ), a distal end ( 24 ), and a channel ( 26 ) extending therebetween. The valve further includes a stationary body ( 30 ) comprising a base ( 32 ) and a stem ( 34 ), the stem being disposed within the channel of the stopper when the stopper is in the second position. When the stopper is in the first position, there is a liquid-tight seal in the channel, such that fluid flow through the channel is prevented. Movement of the stopper to the second position terminates the liquid-tight seal, thereby establishing fluid communication through the channel. A drug containing device and assembly for delivering a reconstituted drug are also provided herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to drug reconstitution devices and, moreparticularly, to a valve for permitting the mixing of at least twosubstances within a medical injector or drug cartridge.

2. Description of Related Art

Certain drugs or medicaments (those terms being used interchangeablyherein) are preferably provided in powder or dry form (such as alyophilized form), and require reconstitution prior to administration.Lyophilized drugs, for example, typically are supplied in a freeze-driedform that needs to be mixed with a diluent to reconstitute the substanceinto a form that is suitable for injection. Medicaments may also beprovided in other dry or powder forms that require reconstitution.

In addition, drugs may be provided as multi-part systems which requiremixing prior to administration. For example, one or more liquid (e.g.,flowable (slurry or liquid)) components, and/or dry (e.g., powdered orgranular) components may be provided in a drug container or deliverydevice which require mixing prior to administration. Gondatropin andinterferon are examples of such multi-component substances which aretypically mixed just prior to being administered to a patient.

Prior art devices have been developed that provide a wet component(e.g., liquid) and a dry component (e.g., powder) in separate chambersof a common container with the container being configured to permit theflow of the wet component to the dry component to cause mixing thereofin preparing an administratable solution for injection. The priordevices typically include a bypass channel formed in the container and,as such, the device must be specifically configured for mixing.

Alternatively, prior devices for facilitating the mixing of a wetcomponent and a dry component within a syringe barrel or drug deliverycartridge disclose a valve initially in a closed position whichtransitions to an open position in response to pressure applied to thevalve from the liquid component. Specifically, force from the liquidcomponent overcomes frictional forces between the elements of the valveto open a channel in the valve for the liquid component to pass through.However, these prior valves may fail to open if the frictionalengagement between valve elements is too great to be overcome by thefluid force exerted on the valve. In that case, the valve may slipthrough the barrel instead of opening correctly.

Therefore, there is a need for a reconstitution device which permitsmixing of two or more components within a single syringe barrel or drugdelivery cartridge and subsequent injection thereof. The cartridge orbarrel should not need to be specifically configured for mixing. Inaddition, the device should have high reliability and, specifically,should not rely on differential frictional forces to transition thevalve from a closed to an open position. Finally, the device should havesufficient barrier properties to maintain separation of wet and drycomponents for long-term storage.

SUMMARY OF THE INVENTION

Provided herein is a valve configured to be received within a syringebarrel or drug delivery cartridge for maintaining prolonged separationbetween one or more components of a drug to be reconstituted and whichallows for mixing of the one or more components within the barrel orinjector prior to expulsion of the reconstituted fluid. A drug deliverydevice including a valve and an expulsion element for propelling acomponent of the drug to be reconstituted through the valve and forexpelling the reconstituted fluid from the device is also provided.Additionally, a drug delivery assembly including a drug delivery device,valve, dry component of a drug to be reconstituted, and wet component ofa drug to be reconstituted is also provided.

In accordance with one embodiment of the present invention, a valve forpermitting mixing of at least two components within a barrel includes astopper disposed within the barrel configured for slidable liquid-tightengagement with an inner surface of the barrel. The stopper is moveablebetween a first position and a second position and includes a proximalend, a distal end, and a channel extending therebetween. The valvefurther includes a stationary body disposed at least partially withinthe barrel comprising a base and a stem, the stem being disposed withinthe channel of the stopper when the stopper is in the second position.When the stopper is in the first position, there is a liquid-tight sealin the channel, such that fluid flow through the channel is prevented.Movement of the stopper to the second position terminates theliquid-tight seal, thereby establishing fluid communication through thechannel and defining a liquid flow path from the proximal end of saidstopper to a distal end of the barrel. The base of the body may sit onan internal shoulder located at the distal end of the barrel.

In certain configurations, the stopper includes a pierceable septumlocated in the channel of the stopper which creates the liquid-tightseal. Further, a proximal portion of the stem may have a tip forpiercing the pierceable septum when the stopper is moved to the secondposition.

In other configurations, at least a portion of the stem is disposedwithin the channel of the stopper in the first position and engages withthe channel to form the liquid-tight seal. Further, the stem of the bodymay further include a port extending from the proximal end of the stemto the base for permitting fluid flow from the channel of the stopper toa distal portion of the barrel according to the liquid flow path whenthe stopper is in the second position. Additionally, the proximal end ofthe channel has a larger diameter than the distal end of the channel,such that movement of the stopper to the second position disengages thestem from the channel and advances the stem farther within the channel.

In accordance with another embodiment of the present invention, a drugcontaining device includes a barrel having a proximal end and a distalend and a valve disposed in said barrel. The valve includes a stopperdisposed within the barrel configured for slidable liquid-tightengagement with an inner surface of the barrel and moveable between afirst position and a second position, the stopper having a proximal end,a distal end, and a channel extending therebetween and a stationary bodydisposed at least partially within the barrel comprising a base and astem, the stern being disposed within the channel of the stopper whenthe stopper is in the second position. When the stopper is in the firstposition, there is a liquid-tight seal in the channel, such that fluidflow through the channel is prevented. Movement of the stopper to thesecond position terminates the liquid-tight seal, thereby establishingfluid communication through the channel and defining a liquid flow pathfrom the proximal end of said stopper to a distal end of the barrel. Thebarrel may include an inner shoulder located on the distal end of thebarrel. The base of the body may sit on the inner shoulder of thebarrel.

In certain configurations, the stopper includes a pierceable septumlocated in the channel of the stopper which creates the liquid-tightseal. Further, a proximal portion of the stem may have a tip forpiercing the pierceable septum when the stopper is moved to the secondposition.

In other configurations, at least a portion of the stem is disposedwithin the channel of the stopper in the first position and engages withthe channel to form the liquid-tight seal. Further, the stem of the bodymay further include a port extending from the proximal end of the stemto the base for permitting fluid flow from the channel of the stopper toa distal portion of the barrel, according to the liquid flow path whenthe stopper is in the second position. Additionally, the proximal end ofthe channel has a larger diameter than the distal end of the channel,such that movement of the stopper to the second position disengages thestem from the channel and advances the stem farther within the channel.

The drug containing device may be an injector or may be a drug deliverycartridge.

In accordance with another embodiment of the present invention, anassembly is provided including a drug delivery device comprising abarrel and a valve. The valve includes a stopper disposed within thebarrel configured for slidable liquid-tight engagement with an innersurface of the barrel and moveable between a first position and a secondposition, the stopper having a proximal end, a distal end, and a channelextending therebetween and a stationary body disposed at least partiallywithin the barrel comprising a base and a stem, the stem being disposedwithin the channel of the stopper when the stopper is in the secondposition. When the stopper is in the first position, there is aliquid-tight seal in the channel, such that fluid flow through thechannel is prevented. Movement of the stopper to the second positionterminates the liquid-tight seal, thereby establishing fluidcommunication through the channel and defining a liquid flow path fromthe proximal end of said stopper to a distal end of the barrel. Theassembly further includes a dry component disposed within said barreldistally of said valve and a liquid component for reconstituting saiddry component disposed within said barrel proximally of said valve.

In certain configurations, the assembly further includes a plungerdisposed initially in the proximal end of the barrel, wherein advancingthe plunger toward the distal end of the barrel causes the stopper tomove distally from the first position to the second position.Optionally, continued distal movement of the plunger advances thestopper to a third position in which the stopper abuts the base of thebody thereby causing the reconstituted dry and liquid components to beexpelled from a nozzle located at the distal end of the barrel.

In accordance with another embodiment of the present invention, a valvefor permitting mixing of at least two components within a barrelincludes a moveable stopper disposed within the barrel configured forslidable liquid-tight engagement with the inner surface of the a barrelhaving a proximal end, a distal end, and a channel extendingtherebetween. The valve further includes a removable cap comprising abase and a pin, the pin having a distal end connected to the base and aproximal end disposed within the fluid channel of the stopper. When thestopper is in a first position, the stem of the cap forms a liquid-tightseal in the channel of the stopper such that fluid flow through thechannel is prevented. When the cap is removed from the barrel, fluidcommunication through the fluid channel is established, thereby defininga liquid flow path from the proximal end of said stopper to a distal endof the barrel.

BRIEF DESCRIPTION OF THE DRAWINGS

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

FIG. 1A is a cross-sectional perspective view of a valve forreconstitution disposed within a syringe barrel and configured in thefirst or storage position in accordance with an embodiment of thepresent invention.

FIG. 1B is a cross-sectional perspective view of the valve of FIG. 1A inthe second or mixed position in accordance with an embodiment of thepresent invention.

FIG. 1C is a cross-sectional perspective view of the valve of FIG. 1A inthe third position in accordance with an embodiment of the presentinvention.

FIG. 1D is an enlarged partial cross-sectional perspective view of thevalve of FIG. 1A in the second position showing liquid flow through thestopper in accordance with an embodiment of the present invention.

FIG. 2A is a side view of the valve body of the valve of FIG. 1A inaccordance with an embodiment of the present invention.

FIG. 2B is a bottom view of the valve body of the valve of FIG. 1A inaccordance with an embodiment of the present invention.

FIG. 3A is a cross-sectional perspective view of a valve forreconstitution disposed within a syringe barrel and configured in thefirst or storage position in accordance with a second embodiment of thepresent invention.

FIG. 3B is a cross-sectional perspective view of the valve of FIG. 3A inthe second or mixed position in accordance with an embodiment of thepresent invention.

FIG. 3C is a cross-sectional perspective view of the valve of FIG. 3A inthe third position in accordance with an embodiment of the presentinvention.

FIG. 3D is an enlarged partial cross-sectional perspective view of thevalve of FIG. 3A in the second position showing liquid flow through thestopper in accordance with an embodiment of the present invention.

FIG. 4A is a side view of the valve body of the valve of FIG. 3A inaccordance with an embodiment of the present invention.

FIG. 4B is a bottom view of the valve body of the valve of FIG. 3A inaccordance with an embodiment of the present invention.

FIG. 5A is a cross-sectional perspective view of a valve forreconstitution disposed within a syringe barrel and configured in thefirst or storage position in accordance with a third embodiment of thepresent invention.

FIG. 5B is a cross-sectional perspective view of the valve of FIG. 5A inthe second or mixed position in accordance with an embodiment of thepresent invention.

FIG. 5C is a cross-sectional perspective view of the valve of FIG. 5A inthe third position in accordance with an embodiment of the presentinvention.

FIG. 5D is an enlarged partial cross-sectional perspective view of thevalve of FIG. 5A in the second position showing liquid flow through thestopper in accordance with an embodiment of the present invention.

FIG. 6 is a partial cross-sectional perspective view of a portion of thecap of the valve of FIG. 5A in accordance with an embodiment of thepresent invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purpose of facilitating understanding of the invention, theaccompanying drawings and description illustrate preferred embodimentsthereof, from which the invention, various embodiments of itsstructures, construction and method of operation, and many advantagesmay be understood and appreciated.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume alternative variations and step sequences,except where expressly specified to the contrary. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the invention. Hence, specificdimensions and other physical characteristics related to the embodimentsdisclosed herein are not to be considered as limiting.

With reference to FIGS. 1A-1C, a valve 10 is shown for permitting mixingof at least two components. As further discussed below, the valve 10 isparticularly well-suited for use with reconstitution of one or moredrugs in which one component is a wet (e.g., liquid) component suitablefor reconstituting a dry (e.g., lyophilized powder) component. The valve10 may be used and disposed within a barrel of an injector (i.e., amedical injector), such as a syringe or pen injector, or in the barrelof a drug cartridge.

As depicted in FIG. 1A, a barrel 12 may be in the general form of anelongated cylindrical barrel, although other forms for containing afluid for delivery are also contemplated by the present invention.Additionally, the barrel 12 may be formed of glass, or may be injectionmolded from thermoplastic material such as polypropylene andpolyethylene according to techniques known to those of ordinary skill inthe art, though it is to be appreciated that the barrel 12 may be madefrom other suitable materials and according to other applicabletechniques. The barrel 12 may include markings, such as graduations onthe wall thereof, for providing an indication as to the level or amountof fluid contained within the barrel. Such markings may be provided onthe external wall, the internal wall, or integrally formed or otherwisewithin the wall of the barrel 12. Alternatively, or in addition thereto,the markings may provide a description of the contents of the syringe,or other identifying information, as may be known in the art. Holdingshoulders 18, formed by the sidewalls of a nozzle 16, are located at thedistal end of the barrel 12.

As will be recognized by those skilled in the art, the valve 10 may beused to permit mixing of various components, such as one or more wetcomponents, which may be in any flowable form, such as in a liquid,syrup, or slurry form, and/or one or more dry components, which may bein powder or granular form.

With reference to FIGS. 1A-2B, the valve 10 generally includes a stopper20 and a body 30. The stopper 20 is configured to be in slidingliquid-tight engagement with the interior of a sidewall 13 of the barrel12. The stopper 20 may be formed of an elastomeric material, and mayinclude a proximal end 22, a distal end 24, and a channel 26 definedtherein and extending at least partially therebetween. In onenon-limiting embodiment of the invention, the channel 26 defines alarger diameter D₁ at the proximal end 22 of the stopper 20 and asmaller diameter D₂ at the distal end 24. One or more ribs 28 may beformed circumferentially about the stopper 20 to enhance the integrityof the liquid-tight seal formed between the stopper 20 and the barrel12. The stopper 20 is moveable within the barrel 12 from a first orstorage position (see FIG. 1A), to a mixing or second position (see FIG.1B), to a dispersal or third position (see FIG. 1C).

With reference now to FIG. 2A, the body 30 of the valve 10 generallyincludes a base 32 and a stein 34 connected to the base 32. The base 32may be formed of various materials, including rigid plastics, and may bemanufactured using, among other techniques, injection molding. In oneembodiment, the base 32 is restrained by holding shoulders 18, as shownin FIGS. 1A-1C. The stem 34 may also be formed from rigid plastics or,alternatively, from metal. In certain configurations, the base 32 andthe stem 34 may be co-formed. The stem 34 includes a proximal end 36 anda distal end 38. The proximal end 36 is adapted to be disposed withinthe channel 26 of the stopper 20. The distal end 38 is connected to thebase 32. In one embodiment, the stem 34 extends from the base 32 in asubstantially perpendicular orientation. The stem 34 further includes aport 40 extending longitudinally along at least a portion of the stem34.

In the first position, as shown in FIG. 1A, a liquid-tight seal isformed within the channel 26 to prevent fluid flow through the channel26. According to one non-limiting embodiment of the invention, theliquid-tight seal is formed as a result of engagement between the stem34 of the body 30 and channel 26 of the stopper 20. As depicted in FIG.1A, the entirety of the port 40 is located distally from the stopper 20in the first position. Thus, the port 40 is not disposed within thechannel 26 of the stopper 20 in the first position. To enhance theintegrity of the liquid-tight seal, one or more sealing ribs 42 may bedefined on the proximal end 36 of the stem 34 and/or may extend from theinner surface of the channel 26. As depicted in FIG. 2B, the base 32further includes a slit 44 extending radially outward from the centralportion of the base. The slit 44 allows fluid to pass through the base32 to be expelled from the barrel 12 through the nozzle 16.

In use, the valve 10 is disposed within the interior of the barrel 12separating the barrel 12 into a first chamber 52 and a second chamber50. The first chamber 52 may be distal to the valve 10 and the secondchamber 50 may be proximal to the valve 10. A dry component, such as adry medicament, may be provided within the first chamber 52 and a wetcomponent, such as a liquid suitable for reconstituting the drycomponent, may be disposed within the second chamber 50. With referenceto FIG. 1A, the valve 10 is initially in a closed position. In theclosed position, the stem 34 defines the liquid-tight seal in thechannel 26, such that liquid flow L (FIG. 1D) through the channel 26 isprevented. In addition, the liquid-tight seal defined between thestopper 20 and the barrel 12 prevents liquid flow about the stopper 20.Therefore, the dry component housed in the first chamber 52 may bemaintained in a dry state during storage or transportation.

When ready for use, pressure is applied to the wet component housed inthe second chamber 50 in any known manner, including through a manual orautomatic application of force. With reference to FIG. 1A, in onenon-limiting embodiment of the present invention, pressure is applied bya plunger 60 disposed within the barrel 12 located at a proximalposition relative to the wet component housed in the second chamber 50.The plunger 60 may optionally be connected to a plunger rod (not shown)at a connection joint 62. The connection joint 62 may be configured sothat the plunger rod screws into the plunger 60. Applying downward forceto the plunger 60 in the direction of arrow F, as shown in FIG. 1D,distally advances the plunger 60 through the barrel 12.

With the fluid component housed in second chamber 50 beingincompressible or generally incompressible, the applied pressure istransmitted through the fluid component to the stopper 20. The appliedforce causes the stopper 20 to move distally through the barrel 12 whilethe body 30 remains stationary. With the proximal portion of the channel26 having a larger diameter than the distal portion, the stem 34, whichinitially defines the liquid-tight seal with the channel 26, comes outof engagement with the channel 26. Continued distal movement of thestopper 20 brings the stem 34 further into the channel 26, therebyestablishing fluid communication through the channel 26 of the stopper20 and port 40 of the stem 34. As such, a liquid flow path L (FIG. 1D)is defined through the channel 26 and port 40.

With continued reference to FIG. 1B, under further application ofpressure, the valve 10 is fixed relative to the barrel 12 due to thefrictional resistance against movement generated at the interfacebetween the stopper 20 and the barrel 12. At this point the fluidcomponent housed within second chamber 50 is forced through the channel26 and port 40 according to liquid flow path L, as shown in FIG. 1D. Theliquid component housed within second chamber 50 is forced throughchannel 26 and port 40 to enter the first chamber 52 housing the drycomponent. In this way, the liquid component housed in second chamber 50is reconstituted with the dry component housed in first chamber 52producing a solution which is ready for injection. The solution mayinclude a pharmaceutically active agent.

With reference now to FIG. 1C, once the liquid component housed in firstchamber 52 is forced through the stopper channel 26, the plunger 60 isbrought into abutting engagement with the proximal end 22 of the stopper20. Continued application of force in the direction of arrow F, as shownin FIG. 1C, moves the plunger 60 and stopper 20 through the barrel 12 inthe distal direction toward the reconstituted fluid. The reconstitutedfluid is then dispersed from the barrel 12 by passing through the slit44 of the base 32 and through the nozzle 16.

The valve 10 may be used in similar manner to mix one or more wetcomponents, e.g., wet components being located on both sides of thevalve 10. A series of the valves 10 may also be used to allow for mixingof a plurality of wet and/or dry components.

With reference now to FIGS. 3A-4B, a valve 110 is similarly presentedaccording to another non-limiting embodiment of the present invention.In this embodiment, a stem 134 of a body 130 comprises a needle 146having a tip 148. The tip 148 is adapted to engage with a pierceableseptum 128 of a stopper 120. A base 132 further includes a plurality ofdispersion ports 144, as shown in FIG. 4B, for allowing thereconstituted fluid to pass through the base 132 for dispersal from abarrel 112. As in the embodiment of the invention described above withreference to FIGS. 1A-2B, the base 132 is restrained by holdingshoulders 118 of the barrel 112.

In the first position (see FIG. 3A), the pierceable septum 128 forms theliquid-tight seal within a channel 126. As with the embodiment describedabove with reference to FIGS. 1A-2B, when ready for use, pressure isapplied to the liquid component housed in a second chamber 150, throughany known means including driving a plunger 160 through the barrel 112,causing the stopper 120 to descend distally through the barrel 112. Thebody 130 and, specifically, the stem 134 remain stationary. The distalmovement of the stopper 120 brings the pierceable septum 128 intocontact with the tip 148 of the needle 146 of the stem 134. Furtherpressure pierces the septum 128 establishing a liquid flow path L₁ (seeFIG. 3D) through the stopper 120.

With continued reference to FIG. 3B, further application of pressureforces the fluid component housed within second chamber 150 through thestopper 120, thereby introducing the liquid component to the drycomponent housed within a first chamber 152 for reconstitution. Thereconstituted fluid is dispersed through a nozzle 116 in the same manneras described for the previous embodiment of the invention.

With reference to FIGS. 5A-6, a further non-limiting embodiment of avalve 210 of the present invention is depicted. The valve 210 comprisesa stopper 220 and a removable cap 230. The cap 230 includes a base 232and a stem 234. In the initial position (see FIG. 5A), the base 232 islocated outside a barrel 212. The stem 234 extends into the barrel 212through the nozzle 216, such that a proximal end 236 of the stem 234 isdisposed within a channel 226 of the stopper 220 forming a liquid-tightseal. When ready for use, a user removes the cap 230, thereby removingthe stem 234 from the channel 226 to establish fluid communicationthrough the channel 226 of the stopper 220 along liquid flow path L₂(see FIG. 5D). Application of pressure to the liquid component housedwithin a second chamber 250 forces the liquid component through thechannel 226, along path L₂, thereby forcing the liquid component intofirst chamber 252 housing the dry component for reconstitution.Continued application of pressure advances the stopper 220 distallythrough the barrel 212, thereby dispensing the reconstituted fluid fromthe barrel 212 through the nozzle 216 in the same manner as describedabove for previous embodiments of the invention.

What is claimed is:
 1. A valve for permitting mixing of at least two components within a medical barrel comprising: a stopper disposed within the barrel configured for slidable engagement with an inner surface of the barrel and moveable between a first position and a second position, the stopper having a proximal end, a distal end, and a channel extending therebetween; and a stationary body disposed at least partially within the barrel comprising a base and a stem, the stem defining a port therein and being disposed within the channel of the stopper when the stopper is in the second position, wherein when the stopper is in the first position, the port is isolated from the channel and fluid flow through the channel is prevented, and wherein movement of the stopper from the first position to the second position establishes fluid communication through the port and channel.
 2. The valve of claim 1, wherein the at least two components include at least one liquid component and at least one dry component.
 3. The valve of claim 1, wherein the stopper includes a pierceable septum dispersed therein.
 4. The valve of claim 3, wherein a proximal portion of the stem comprises a tip for piercing the pierceable septum when the stopper is moved to the second position.
 5. The valve of claim 1, wherein the stem is disposed within the channel of the stopper in the first position and cooperates with the channel to form a liquid-tight seal therewith.
 6. The valve of claim 1, wherein the channel includes a proximal end having a first diameter, and a distal end having a second diameter, wherein the first diameter is larger than the second diameter.
 7. A drug containing device comprising: a barrel having a proximal end and a distal end; a valve disposed in said barrel, said valve including: a stopper disposed within the barrel configured for slidable engagement with an inner surface of the barrel and moveable between a first position and a second position, the stopper having a proximal end, a distal end, and a channel extending there between; and a stationary body disposed at least partially within the barrel comprising a base and a stem, the stem defining a port therein and being disposed within the channel of the stopper when the stopper is in the second position, wherein when the stopper is in the first position, the port is isolated from the channel and fluid flow through the channel is prevented, and wherein movement of the stopper from the first position to the second position establishes fluid communication through the port and channel.
 8. The device of claim 7, wherein the barrel further includes an inner shoulder adjacent the distal end of the barrel, and wherein the base of the body contacts the inner shoulder of the barrel.
 9. The device of claim 7, wherein the valve is configured for mixing at least two components within the barrel.
 10. The device of claim 9, wherein the at least two components include at least one liquid component and at least one dry component.
 11. The device as in claim 7, wherein the stopper includes a pierceable septum disposed therein.
 12. The device of claim 7, wherein a proximal portion of the stem comprises a tip for piercing the pierceable septum when the stopper is moved to the second position.
 13. The device of claim 7, wherein the stem is disposed within the channel of the stopper in the first position and cooperates with the channel to form a liquid-tight seal therewith.
 14. The device of claim 7, wherein the stem further includes a port extending from a proximal end of the stem to the base for permitting fluid flow from the channel of the stopper to a distal portion of the barrel when the stopper is in the second position.
 15. The device of claim 7, further comprising a plunger disposed initially in the proximal end of the barrel wherein advancing the plunger toward the distal end of the barrel causes the stopper to move distally from the first position to the second position.
 16. The device of claim 15, wherein continued distal movement of the plunger advances the stopper to a third position in which the stopper abuts the base of the body.
 17. The device of claim 7, wherein the device is an injector.
 18. The device of claim 7, wherein the device is a drug cartridge.
 19. An assembly comprising: a drug delivery device comprising: a barrel having a proximal end and a distal end; a valve disposed in said barrel, said valve including: a stopper disposed within the barrel configured for slidable engagement with an inner surface of the barrel and moveable between a first position and a second position, the stopper having a proximal end, a distal end, and a channel extending therebetween; and a stationary body disposed at least partially within the barrel comprising a base and a stem, the stem defining a port therein and being disposed within the channel of the stopper when the stopper is in the second position, wherein when the stopper is in the first position, the port is isolated from the channel and fluid flow through the channel is prevented, and wherein movement of the stopper from the first position to the second position establishes fluid communication through the port and channel; a dry component disposed within the barrel distally of the valve; and a liquid component for reconstituting the dry component disposed within the barrel proximally of the valve.
 20. The assembly of claim 19, further comprising a plunger disposed initially in the proximal end of the barrel, wherein advancing the plunger toward the distal end of the barrel causes the stopper to move distally from the first position to the second position.
 21. The assembly of claim 20, wherein continued distal movement of the plunger advances the stopper to a third position in which the stopper abuts the base of the body, thereby causing the reconstituted dry and liquid components to be expelled from a nozzle located at the distal end of the barrel.
 22. The assembly of claim 19, wherein the device is an injector.
 23. The assembly of claim 19, wherein the device is a drug cartridge.
 24. A bypass valve for permitting mixing of at least two components within a barrel having a proximal end and a distal end comprising: a moveable stopper disposed within the barrel configured for slidable liquid-tight engagement with an inner surface of the barrel having a proximal end, a distal end, and a fluid channel extending therebetween; and a removable cap comprising a base and a pin, the pin having a distal end connected to the base and a proximal end disposed within the fluid channel of the moveable stopper; wherein, when the moveable stopper is in a first position, the pin of the cap forms a liquid-tight seal with the fluid channel of the stopper such that fluid flow through the fluid channel is substantially prevented and wherein when the cap is isolated from the barrel, fluid communication through the fluid channel is established thereby defining a liquid flow path from the proximal end of the stopper to the distal end of the barrel. 